Quote: BTD is granted to clinical-stage drugs tha
Post# of 148112
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Posted On: 01/06/2022 5:32:28 PM
Re: generactor #114046
Quote:
BTD is granted to clinical-stage drugs that provide a substantial benefit over SOC (approved therapies).
Ok, but didn't we know that? If my aged and abused memory serves we discussed Trodelvy's data here fairly thoroughly. Nader even brought up that our data was continuing to sixteen months a few weeks ago. How many patients are there? How hard is it to find out if they are still alive? Shouldn't CYDY be notified when/if they die? Do FDA rules allow an updated addendum for a BTD? Is there more comprehensive data that needs to accompany dead/alive data? If so shouldn't we already have it? Pickled minds want to know.
BTD is granted to clinical-stage drugs that provide a substantial benefit over SOC (approved therapies).
Ok, but didn't we know that? If my aged and abused memory serves we discussed Trodelvy's data here fairly thoroughly. Nader even brought up that our data was continuing to sixteen months a few weeks ago. How many patients are there? How hard is it to find out if they are still alive? Shouldn't CYDY be notified when/if they die? Do FDA rules allow an updated addendum for a BTD? Is there more comprehensive data that needs to accompany dead/alive data? If so shouldn't we already have it? Pickled minds want to know.
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